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Her fearful discovery

North Shore LIJ patient, among 42 notified of possible faulty transplants, says she has syphilis

BY SAMUEL BRUCHEY | STAFF WRITER

January 5, 2006

A Franklin Square woman found out she has syphilis a month after her hospital told her that tissue used in her bone graft may not have been screened for infectious diseases, the woman and her attorney said yesterday.

"I'm upset," said Patricia Battisti, 41, a single mother of four who underwent surgery last January in Valley Stream to alleviate back pain from a 2003 car crash. "I'm very upset, disappointed and scared."

Battisti was one of 42 patients at North Shore Long Island Jewish hospitals who received letters from the hospital system last month saying body parts sold to tissue banks from a New Jersey company may not have been tested or sterilized. Those parts were then sold to hospitals on Long Island and across the country.

Battisti and 16 other North Shore LIJ patients, some of whom say they never received the letter, are considering filing a malpractice suit against the hospital system and its physicians, attorney Jeffrey Lisabeth of Mineola said.

"It is the absolute ... obligation of the hospital and physician to make sure [tissue] is reasonably safe," Lisabeth said. "Here they did nothing."

But FDA spokeswoman Julie Zawisza said tissue banks - not hospitals - are obligated to test body parts and ensure they are disease-free. A hospital's only obligation is to purchase body parts from accredited tissue banks, she said.

"There's the assumption, when getting tissue, that it has been inspected and that it is safe," Terry Lynam, director of communications at North Shore LIJ, said.

In October, the FDA notified hospitals across the country, including North Shore LIJ, about allegations that Biomedical Tissue Services of Fort Lee, N.J., had purchased body parts stolen by English Brothers Funeral Home from Brooklyn graveyards.

Biomedical is accused of passing those parts along to five tissue banks located in Georgia, Texas, New Jersey and two in Florida, which re-sold them to hospitals.

Zawisza said she didn't know how many other hospitals had received the potentially infected parts from Biomedical, or how many patients had received them in operations. She would not say if the FDA had been notified by other patients who had tested positive to diseases including HIV, hepatitis and syphilis.

Calls to Biomedical and English Brothers Funeral Home were not returned.

Wendy Crites-Wacker, director of corporate communications at Regeneration Technologies Inc. of Alachua, Fla., which sold the bone used in Battisti's surgery, said it tests and sterilizes all tissue before it is sold. The process takes six hours and exceeds FDA regulations, she said.

"We are highly confident of the safety," Crites-Wacker said.

North Shore LIJ did more than it had to when it told its patients about the FDA notification, Lynam said. "We have been singled out for a beating for doing the right thing," Lynam said, noting that all of Long Island's hospitals got the same notification from the FDA.

A spokesman at Winthrop-University Hospital in Mineola said it mailed letters to eight patients after hearing from the FDA and has offered free testing. The spokesman declined to discuss any test results. Calls to several other Long Island hospitals yesterday were not returned.

After informing its 42 patients, North Shore LIJ contacted tissue banks to make sure that parts used at its hospitals were disease-free.

Dr. Bruce Farber, chief of infectious diseases at the hospital system, said infectious diseases are rarely transmitted during organ or blood transfusions and have never been contracted during a bone graft.

"It would be literally unprecedented," Farber said, adding that viruses can't survive on bones because they are too dry.

But Battisti said she tested negative for sexually transmitted diseases just before the procedure at Franklin Hospital Medical Center and could not have contracted syphilis any other way since. "The tests always came back negative before," she said.

Selling human tissue

How body parts exhumed in Brooklyn made their way to several LI hospitals

English Brothers Funeral Home allegedly collects human tissue exhumed from a graveyard without families' permission.

Funeral home sells the tissue to Biomedical Tissue Services of Fort Lee, N.J. The body parts are then sold to a number of tissue banks across the country, including LifeCell Corp. of Branchburg, N.J., and Regeneration Technologies Inc. of Alachua, Fla.

The parts then are acquired by four North Shore Long Island Jewish hospitals. The tissue, which might not have been sterilized, might have been used in surgeries on as many as 42 patients. The hospitals are Franklin Hospital Medical Center, Valley Stream; North Shore University Hospital, Manhasset; Huntington Hospital; and Southside Hospital, Bay Shore